Quality Oversight of CROs-Clinical Vendors
June 23 from 9:00AM – 5:00PM
in Boston
FDA and EMA communicate at industry conferences, FDA-CTTI meetings, and
regulatory agency public meetings. Sponsors and CRO-vendors who are transferred
the responsibilities for trial conduct must have in place a vendor
management-oversight program and methods, as well as a quality management
system and risk management framework for the execution of clinical trials.
Building upon this framework and benchmarking to ISO-9001: 2008, Quality
Management Systems, this tutorial describes Quality Oversight of Vendors, with
the focus on quality systems, quality attributes, and performance monitoring.
Instructor(s):
Liz Wool, BSN,RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States
Jennifer J Poulakos, PhD
Director, Clinical Quality Assurance
Astellas, United States
Jeffery Baldwin, BSN,RN
Senior Manager, Supplier Governance
Amgen, United States
What’s more…Receive $100 off of your DIA 2013 Annual
Meeting registration by registering for two half day tutorials or one full day
tutorial. Please note purchases must be made at the same time in order to
receive the discount.
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